Committee for Medicinal Products for Human Use (CHMP) recommend addition of a new pharmaceutical form of daratumumab (Darzalex)

CHMP recommend addition of a solution for injection associated with a new strength (1800 mg in 15ml vial) and new route of administration (subcutaneous injection). New formulation can be used for all existing licensed indications e.g. treatment of multiple myeloma.


European Medicines Agency